FDA Device recall Z-0945-2017
Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surger…
- FDA Device
- Class II
- terminated
- Published 2017-01-11
On 2017-01-11 the FDA classified a Class II recall of Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surger… by Smith And Nephew, citing all lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0945-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-15 |
| Published | 2017-01-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are intended for single use only and are to be implanted without bone cement.
Reason
All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
Identifiers
| code_info | 71352401 SMF STEM RSA SIZE 1 71352402 SMF STEM RSA SIZE 2 71352403 SMF STEM RSA SIZE 3 71352404 SMF STEM RSA SIZE 4…71352401 SMF STEM RSA SIZE 1 71352402 SMF STEM RSA SIZE 2 71352403 SMF STEM RSA SIZE 3 71352404 SMF STEM RSA SIZE 4 71352405 SMF STEM RSA SIZE 5 71352406 SMF STEM RSA SIZE 6 71352407 SMF STEM RSA SIZE 7 71352408 SMF STEM RSA SIZE 8 71352409 SMF STEM RSA SIZE 9 71352501 SMF STEM WITH STIKTITE SZ 1 71352502 SMF STEM WITH STIKTITE SZ 2 71352503 SMF STEM WITH STIKTITE SZ 3 71352504 SMF STEM WITH STIKTITE SZ 4 71352505 SMF STEM WITH STIKTITE SZ 5 71352506 SMF STEM WITH STIKTITE SZ 6 71352507 SMF STEM WITH STIKTITE SZ 7 71352508 SMF STEM WITH STIKTITE SZ 8 71352509 SMF STEM WITH STIKTITE SZ 9 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0945-2017%22
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